11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Uni-port
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Capo Slow Flow A 2, 2 g
FDA UDI
Schütz Dental GmbH·ESDG2320621·Capo Slow Flow is a light-curing, flowable, hig...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESIE APPS SUITE
FDA 510(k)
FDA Class 2
·Radiology
ENDOVIVE? SECURI-T?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·November 6, 2014
ASR 300 SPIKED CUP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
TAPERLOC POROUS FEMORAL 13.5X147
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·July 17, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014